U.S. Pat. No. 6,057,097, incorporated per reference, disclosed markers for pathologies comprising an autoimmune reaction and markers for inflammatory diseases.
As disclosed in this document, numerous pathologies comprising an autoimmune reaction and inflammatory diseases have an uncertain or unknown etiology and may have a multifactor origin.
The diagnosis of some of these diseases is difficult or uncertain. One disease especially mentioned in this document is systemic lupus erythematosus (SLE). Prior to U.S. Pat. No. 6,057,097 it had not been possible to provide a sufficient specific antigenic structure to obtain a reliable diagnosis both in specificity and sensitivity for the mentioned pathologies, especially SLE.
U.S. Pat. No. 6,057,097 solves the problem by providing an antigenic structure named cytoplasmic-membrane associated DNA (cmDNA) or membrane DNA (mDNA).
This antigen is recognized by antibodies present in biological fluids of subjects suffering from the mentioned diseases. This antigenic structure is prepared from cells especially from β-lymphocytes such as Wil-2 cells.
It is the aim of the present invention to provide an improved antigenic structure and thereby an improved diagnostic tool showing increased specificity and sensibility.
A further aim is to provide a screening method for pharmaceutical substances useful in the treatment of autoimmune diseases and/or inflammations.
A further aim is to provide a pharmaceutical composition.